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510(k) K905528

URESIL VALVE CUTTER by Uresil Corp. — Product Code DWQ

K905528 is an FDA 510(k) premarket notification submitted by Uresil Corp. for the device "URESIL VALVE CUTTER". The FDA issued a decision of Substantially Equivalent on April 18, 1991. The device falls under product code DWQ (Stripper, Vein, External), a Class II device regulated under 21 CFR 870.4885. Uresil Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1991
Date Received
December 10, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stripper, Vein, External
Device Class
Class II
Regulation Number
870.4885
Review Panel
CV
Submission Type

Other clearances by Uresil Corp.

  • K093653 — URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK (February 23, 2010)
  • K053245 — GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CA (December 20, 2005)
  • K041995 — MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETE (August 19, 2004)
  • K003753 — GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIG (January 4, 2001)
  • K980278 — URESIL VASCU-FLO INFUSION CATHETER (November 20, 1998)
  • K981344 — URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING (September 10, 1998)
  • K980282 — URESIL DILATOR WITH RADIOPAQUE MARKER (April 24, 1998)
  • K980889 — URESIL NEPHRO-URETERAL STENT (April 8, 1998)
  • K972582 — URESIL GUIDEWIRE (November 21, 1997)
  • K972583 — URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BI (August 29, 1997)

Other clearances for product code DWQ

  • K212894 — PhasTIPP (March 31, 2022)
  • K041453 — SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 (July 22, 2004)
  • K032387 — TRIVEX SYSTEM (October 29, 2003)
  • K904507 — PILLING BRUSH VALVULOTOME (March 1, 1991)
  • K885046 — INSITUCAT VALVE STRIPPER (February 28, 1990)
  • K872157 — HALL VEIN STRIPPER (July 7, 1987)
  • K811910 — VEIN-TRAP TM (July 20, 1981)

FDA data resources